compounding HOTLINE

FEBRUARY 01, 2007

Martin A. Erickson III, RPh

Q:
I have worked locum tenens in several different pharmacies,
each of which makes various mouthwashes
for postirradiation pain and infections. These formulations
are FIRST, Malik's, Gillespie's, and Magic Mouthwashes. Isn't
there one way to compound each of these preparations? I
keep seeing differences among the pharmacies.

A:
An advantage of extemporaneous compounding is its
flexibility?the pharmacist can tailor therapy to meet
a particular patient's requirements. Usually, interaction with
the patient and physician is required to accomplish such targeted
therapy. The process of developing compounded formulations
requires a pharmacist's special knowledge and
skills.

"Magic Mouthwash" (for want of a better category name)
formulations are as varied as the patients treated and the
prescribers who diagnose. For example, postirradiation
burns are often treated with a formulation of nystatin,
diphenhydramine, lidocaine, and antacid suspension such as
Maalox. Sometimes an antibiotic such as tetracycline is
added. A number of different regional names are applied to
various formulations, and, within a region, variations on the
main theme are often found. Stanford Mouthwash and
Powell's Mouthwash are 2 such "named formulations," but
variations abound.

A central point to consider is that strict adherence to a
particular compounded formulation is important to providing
consistent care to a particular patient. When a particular
formulation appears to provide relief for a patient, that
patient should always obtain the same formulation compounded
the same way.

Compounding differs from manufacturing?current Good
Manufacturing Practices promulgated by the FDA require
strict adherence to formulations in manufactured drug products.
Extemporaneous compounding is not manufacturing
but is the province of the pharmacist. It should be carried out
with adherence to principles of pharmacy practice (cf USP
28<795> and <797>).